Plaquenil

SIDE EFFECTS

MALARIA

Following the administration in doses adequate for the treatment of an acute
malarial attack, mild and transient headache, dizziness, and gastrointestinal
complaints (diarrhea, anorexia, nausea, abdominal cramps and, on rare occasions,
vomiting) may occur. Cardiomyopathy has been rarely reported with high daily
dosages of hydroxychloroquine.

LUPUS ERYTHEMATOSUS AND RHEUMATOID ARTHRITIS

Not all of the following reactions have been observed with every 4-aminoquinoline
compound during long-term therapy, but they have been reported with one or more
and should be borne in mind when drugs of this class are administered. Adverse
effects with different compounds vary in type and frequency.

Neuromuscular Reactions: Skeletal muscle palsies or skeletal muscle
myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal
muscle groups which may be associated with mild sensory changes, depression
of tendon reflexes and abnormal nerve conduction.

Ocular Reactions:

A. Ciliary body: Disturbance of accommodation with symptoms of blurred
vision. This reaction is dose-related and reversible with cessation of therapy.

B. Cornea: Transient edema, punctate to lineal opacities, decreased
corneal sensitivity. The corneal changes, with or without accompanying symptoms
(blurred vision, halos around lights, photophobia), are fairly common, but reversible.
Corneal deposits may appear as early as three weeks following initiation of
therapy.

The incidence of corneal changes and visual side effects appears to be considerably
lower with hydroxychloroquine than with chloroquine.

The most common visual symptoms attributed to the retinopathy are: reading
and seeing difficulties (words, letters, or parts of objects missing), photophobia,
blurred distance vision, missing or blacked out areas in the central or peripheral
visual field, light flashes and streaks.

Retinopathy appears to be dose related and has occurred within several months
(rarely) to several years of daily therapy; a small number of cases have been
reported several years after antimalarial drug therapy was discontinued. It
has not been noted during prolonged use of weekly doses of the 4-aminoquinoline
compounds for suppression of malaria.

Patients with retinal changes may have visual symptoms or may be asymptomatic
(with or without visual field changes). Rarely scotomatous vision or field defects
may occur without obvious retinal change.

Retinopathy may progress even after the drug is discontinued. In a number of
patients, early retinopathy (macular pigmentation sometimes with central field
defects) diminished or regressed completely after therapy was discontinued.
Paracentral scotoma to red targets (sometimes called "premaculopathy") is indicative
of early retinal dysfunction which is usually reversible with cessation of therapy.

A small number of cases of retinal changes have been reported as occurring
in patients who received only hydroxychloroquine. These usually consisted of
alteration in retinal pigmentation which was detected on periodic ophthalmologic
examination; visual field defects were also present in some instances. A case
of delayed retinopathy has been reported with loss of vision starting one year
after administration of hydroxychloroquine had been discontinued.